QA New Product Introduction Responsible

7555-Janssen Pharmaceutica NV Legal Entity; Geel; On-site; EUR 73,000 - 115,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson Innovative Medicine Beerse site seeks a QA Specialist – New Product Introduction (NPI) to provide Quality Assurance oversight for NPI projects, transfers, and implementation activities. You will collaborate with Manufacturing, Engineering, Validation, Regulatory, and Quality teams to ensure GMP-compliant product launches.

The role emphasizes risk management, change controls, and timely QA release of NPI batches to support market supply and readiness.

Qualifications

• University degree in Pharmaceutical Sciences or related field.
• Minimum 2–5 years of experience in pharma manufacturing/quality.
• Knowledge of GMP, ICH guidelines, and regulatory requirements.
• Fluent Dutch and English, written and spoken.

Responsibilities

• Act as QA representative for New Product Introductions and transfers.
• Provide QA oversight for NPI lifecycle and GMP compliance.
• Ensure quality requirements are integrated into early project plans.
• Advise on design, development, and changes to manufacturing/packaging processes.
• Review and approve GMP documents and risk assessments.
• Support inspections, audits, and continuous improvement initiatives.

Skills

Dutch & English

Quality mindset

Cross-functional collaboration

Strong communication

Education

University degree in Pharmaceutical Sciences

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow,and profoundly impact health for humanity.Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Beerse, Antwerp, Belgium

We are searching for the best talent for a QA Specialist – New Product Introduction (NPI). Purpose We are looking for a QA Specialist – New Product Introduction (NPI) to join the Quality organization at Johnson & Johnson Innovative Medicine in Beerse, Belgium. Are you interested in helping bring new products to market while ensuring quality and compliance are embedded from the start? The Quality Department at the Johnson & Johnson Innovative Medicine Supply Chain Beerse site supports all GMP activities related to manufacturing, packaging, labeling, testing, release, and distribution of products manufactured on the Belgium campus. In this role, you will provide Quality Assurance oversight for New Product Introductions (NPI), product transfers, and implementation projects within the Device Assembly and Parenteral Packaging area. Working closely with Manufacturing, Technical Operations, Engineering, Validation, Regulatory Affairs, Supply Chain, and Quality teams, you will help ensure new products and processes are introduced in compliance with GMP requirements, quality standards, and regulatory expectations. You will be responsible for In this role, responsibilities include providing Quality Assurance oversight for New Product Introductions, product transfers, and implementation projects within Device Assembly and Parenteral Packaging. The position contributes to risk management, investigation activities, change management, documentation review, inspection readiness, and project execution while supporting successful product launches and commercial manufacturing readiness.

Key responsibilities include:

• Acting as the QA representative and key quality contact for New Product Introduction, product transfer, and implementation projects
• Providing oversight throughout the NPI lifecycle and helping ensure alignment with GMP requirements, the Quality Management System, and applicable regulatory requirements
• Ensuring quality requirements are incorporated into project plans, processes, and deliverables from an early stage
• Providing QA input into the design, development, and implementation of new or modified manufacturing and packaging processes, equipment, and technologies
• Reviewing and approving GMP documentation, including risk assessments, protocols, reports, procedures, and other project-related documentation
• Applying Quality Risk Management principles throughout projects and helping ensure identified product quality, patient safety, and compliance risks are appropriately mitigated
• Providing quality and compliance expertise for deviations, CAPAs, and Change Controls while helping ensure appropriate investigation and timely resolution
• Assessing the impact of project changes on product quality, validated state, regulatory requirements, and GMP compliance
• Supporting the transfer of new products and processes into operations and helping ensure a robust transition from project phase to routine commercial manufacturing
• Supporting and representing Quality during Health Authority inspections, internal audits, and customer audits
• Driving continuous improvement and lessons-learned activities across NPI programs
• Ensuring timely QA release of NPI batches to support launch and market supply objectives
• Providing QA oversight through routine shop floor walkthroughs and witnessing of critical operational activities

Qualifications / Requirements

Education

University degree in Pharmaceutical Sciences, Chemical Sciences, Biological Sciences, Engineering, or another relevant scientific discipline

Experience

• Minimum 2–5 years of experience within the pharmaceutical industry
• Knowledge & Skills Experience working in GMP-regulated pharmaceutical manufacturing environments
• Strong quality-focused mindset with attention to detail and accuracy
• Experience working independently while maintaining strong stakeholder engagement
• Experience working across cross-functional teams and project environments
• Experience making risk-based decisions in a dynamic and fast-paced environment
• Familiarity with Quality Risk Management principles
• Strong analytical and problem-solving skills
• Continuous improvement mindset
• Knowledge of pharmaceutical legislation, cGMP regulations, ICH guidelines, policies, and procedures
• Strong communication, influencing, and networking skills
• Understanding of the business implications of quality-related decisions
• Fluent Dutch and English, both written and spoken
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

What we offer

We offer a collaborative environment where learning, innovation, and professional development are encouraged. In this role, you will have the opportunity to work across manufacturing, quality, engineering, validation, and regulatory functions while supporting the introduction of new products that help improve patients' lives.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives.

We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.

If you require a reasonable accommodation during the application, interview, or onboarding process, support is available.

Please let us know how we can help.

Required Skills:

Preferred Skills: Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

The anticipated base pay range for this position is: €72 500,00 - €115 230,00

Benefits:

• an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
• Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health.
• We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.